8mm Monopolar Curved Scissors
FDA 510(k) clearance K210478 · decided 2022-09-30
Clearance details
- K-number
- K210478
- Device name
- 8mm Monopolar Curved Scissors
- Applicant
- Iconocare Health
- Decision
- Substantially Equivalent
- Date received
- 2021-02-19
- Decision date
- 2022-09-30
- Days to decision
- 588 days
- Clearance type
- Traditional
- Product code
- QSM
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Scottsdale, AZ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Robotic Surgical Instruments - Permanent Cautery Hook (470183); Robotic Surgical Instruments - Permanent Cautery Spatula (470184) (K252926) | Restore Robotics | 2026-03-26 |
| Remanufactured EndoWrist Cobra Grasper (420190) (K250417) | Rebotix | 2025-08-20 |
| Remanufactured EndoWrist Tenaculum Forceps (420207) (K250539) | Rebotix | 2025-08-19 |
| Remanufactured EndoWrist Long Tip Forceps (420048) (K250387) | Rebotix | 2025-08-19 |
| Remanufactured EndoWrist Cadiere Forceps (420049) (K250399) | Rebotix | 2025-08-19 |
| 8mm Monopolar Curved Scissors (470179) (K242610) | Iconocare Health | 2025-03-11 |
| Remanufactured EndoWrist ProGrasp Forceps (420093) (K241872) | Rebotix | 2024-11-07 |
Recalls involving this device
No recalls on record reference this clearance.